Response of Older Adults to Influenza Vaccination With Regard to Cytomegalovirus (CMV) Status (CMVflu)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00442975|
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : August 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Fluarix||Phase 4|
Human cytomegalovirus (HCMV) is an important pathogen or disease-causing virus, which can result in disease in the unborn child as well as in individuals whose immune systems are not working properly such as those with HIV or who are receiving some treatments for cancer, where the body's ability to fight infection is not as good as in healthy people. HCMV infects the majority of the population, yet rarely causes overt disease which would limit the capacity of the host to transmit HCMV to others. This virus is thought to be millions of years old and because of this we think that it has evolved over time to become very efficient at evading the immune system. This means it has become very efficient at moving through the human population and resulting in humans devoting more immunological resources to controlling this virus than to any other. Recent studies have reported that the immune system does work less efficiently in older people, especially in elderly patients with CMV antibodies compared to age matched controls who did not have CMV antibodies.
It is well recognized that responses to vaccination are generally lower in older populations compared to children, so they may be thought to be immunologically in a suboptimal position. It is proposed that this may be as a result of diversion of key factors in the immune system to address CMV infection, the incidence of which increases with age. This study will allow assessment of responses to licensed seasonal influenza vaccine with respect to age and CMV status and will provide baseline information as a proof of principle on which a larger study will be designed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IV, Single Group Study to Evaluate the Immune Response to Licensed Seasonal Influenza Vaccine and Relationship of This to Cytomegalovirus-associated Immunosenescence in UK Older Adults Aged 50-80 Years|
|Study Start Date :||March 2007|
|Actual Study Completion Date :||September 2007|
- Response to influenza vaccination (HI)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00442975
|Hertfordshire Primary Care Trust|
|Stevenage, United Kingdom|
|Principal Investigator:||Elizabeth Miller, MBBS FRCPath||Public Health England|